Description

Levonorgestrel Impurity N is a specified impurity used as a reference standard in the analytical development and quality control of the active pharmaceutical ingredient (API) Levonorgestrel. This compound is critical for ensuring the purity, safety, and efficacy of pharmaceutical products by enabling accurate identification and quantification of related substances. It is primarily required by pharmaceutical manufacturers, analytical laboratories, and regulatory bodies involved in the development and production of hormonal contraceptives and other steroid-based therapeutics.

Application

• Pharmaceutical Reference Standard: Serves as a certified reference material (CRM) for the identification and quantification of Levonorgestrel Impurity N in API and finished drug product testing.
• Analytical Method Development & Validation: Essential for developing and validating stability-indicating HPLC, UPLC, or GC methods to monitor impurities in Levonorgestrel batches.
• Quality Control & Assurance (QC/QA): Used in routine quality control testing to ensure Levonorgestrel API and formulations meet stringent pharmacopeial (USP, EP, BP) impurity limits.
• Stability Studies: Employed to track the formation of this specific degradation product under various stress conditions (e.g., heat, light, humidity) during drug stability testing.
• Regulatory Submissions: Provides necessary data for regulatory filings (e.g., ANDA, NDA, CTA) to demonstrate comprehensive impurity profiling and control strategies.
• Research & Development: Supports synthetic route optimization and process chemistry research to minimize the formation of this impurity during API manufacturing.

Basic Information

Product Name	Levonorgestrel Impurity N
CAS No.	4222-96-2
Molecular Formula	C21H28O2
Molecular Weight	312.45 g/mol
Synonyms	13-Ethyl-17-hydroxy-18,19-dinor-17α-pregn-4-en-20-yn-3-one; 17α-Ethynyl-18-methyl-19-nortestosterone Impurity N; 17-Hydroxy-13-ethyl-18,19-dinorgona-4-en-20-yn-3-one; Levonorgestrel Related Compound N; D(-)-Norgestrel Impurity N; (8R,9S,10R,13S,14S,17R)-13-ethyl-17-ethynyl-17-hydroxy-1,2,6,7,8,9,10,11,12,14,15,16-dodecahydrocyclopenta[a]phenanthren-3-one
EINECS	Contact for details

Quality Control

Our Levonorgestrel Impurity N is manufactured and handled under strict quality management systems. Each batch undergoes rigorous analytical testing, including identification by spectroscopic methods (IR, NMR, MS), purity determination by HPLC, and control of related substances and residual solvents. A comprehensive Certificate of Analysis (COA) is provided with each shipment, detailing batch-specific results and confirming compliance with in-house specifications. We support compliance with ICH Q3A/B guidelines and relevant pharmacopeial standards for pharmaceutical impurities.

Storage

Preserve in a tightly closed container, protected from light. Store in a cool, dry place at a controlled room temperature (15-25°C). This material is hygroscopic (moisture-sensitive) and should be handled in a low-humidity environment to prevent degradation. For long-term storage, consider desiccation.

Specification

Item	Specification
Appearance	White to off-white powder
Identification (IR)	Conforms to reference spectrum
Identification (HPLC)	Retention time corresponds to reference standard
Purity (HPLC)	≥ 98.0%
Related Substances (HPLC)	Total impurities ≤ 2.0% Any single unknown impurity ≤ 0.5%
Water Content (KF)	≤ 1.0%
Residual Solvents (GC)	Complies with ICH Q3C guidelines

Note: Specifications can be tailored. Please contact us for the detailed technical data sheet of a specific grade.